(5) At each PK sampling point, blood samples (~ 5mL), will be collected in ice-chilled potassium-EDTA sample tubes, each containing pre-added 1% (V:V) of a 1.0 M sodium metabisulfite solution as an antioxidant. Sample tubes will be labeled with a sample ID# (consisting of subject ID#, Study Visit#, and sample#). The sample tubes will be kept on ice or refrigerated, and will be centrifuged within 60 minutes of collection. The harvested plasma from each sample tube will be transferred to, and stored in, 2 storage tubes, respectively, and frozen at NMT -20 degrees C until analysis.